Enriching the concept of vulnerability in research ethics: An integrative and functional account.

The concept of vulnerability is widely used in research ethics to signal attention to participants who require special protections in research. However, this concept is vague and under-theorized. There is also growing concern that the dominant categorical approach to vulnerability (as exemplified by research ethics regulations and guidelines delineating vulnerable groups) is ethically problematic because of its assumptions about groups of people and is, in fact, not very guiding. An agreed-upon strategy is to move from categorical towards analytical approaches (focused on analyzing types and sources of vulnerability) to vulnerability. Beyond this agreement, however, scholars have been advancing competing accounts of vulnerability without consensus about its appropriate operationalization in research ethics. Based on previous debates, we propose that a comprehensive account of vulnerability for research ethics must include four components: definition, normative justifications, application, and implications. Concluding that no existing accounts integrate these components in a functional (i.e., practically applicable) manner, we propose an integrative and functional account of vulnerability inspired by pragmatist theory and enriched by bioethics literature. Using an example of research on deep brain stimulation for treatment-resistant depression, we illustrate how the integrative-functional account can guide the analysis of vulnerability in research within a pragmatist, evidence-based approach to research ethics. While ultimately there are concerns to be addressed in existing research ethics guidelines on vulnerability, the integrative-functional account can serve as an analytic tool to help researchers, research ethics boards, and other relevant actors fill in the gaps in the current landscape of research ethics governance.

The concept of 'vulnerability' in research ethics: an in-depth analysis of policies and guidelines.

BACKGROUND: The concept of vulnerability has held a central place in research ethics guidance since its introduction in the United States Belmont Report in 1979. It signals mindfulness for researchers and research ethics boards to the possibility that some participants may be at higher risk of harm or wrong. Despite its important intended purpose and widespread use, there is considerable disagreement in the scholarly literature about the meaning and delineation of vulnerability, stemming from a perceived lack of guidance within research ethics standards. The aim of this study was to assess the concept of vulnerability as it is employed in major national and international research ethics policies and guidelines. METHODS: We conducted an in-depth analysis of 11 (five national and six international) research ethics policies and guidelines, exploring their discussions of the definition, application, normative justification and implications of vulnerability. RESULTS: Few policies and guidelines explicitly defined vulnerability, instead relying on implicit assumptions and the delineation of vulnerable groups and sources of vulnerability. On the whole, we found considerable richness in the content on vulnerability across policies, but note that this relies heavily on the structure imposed on the data through our analysis. CONCLUSIONS: Our results underscore a need for policymakers to revisit the guidance on vulnerability in research ethics, and we propose that a process of stakeholder engagement would well-support this effort.

The Concept of Vulnerability in Mental Health Research: A Mixed Methods Study on Researcher Perspectives.

The concept of vulnerability plays a central role in research ethics in signaling that certain research participants warrant more careful consideration because their risk of harm is heightened due to their participation in research. Despite scholarly debates, the descriptive and normative meanings ascribed to the concept have remained disengaged from the perspective of users of the concept and those concerned by its use. In this study, we report a survey- and interview-based investigation of mental health researcher perspectives on vulnerability. We found that autonomy-based understandings of vulnerability were predominant but that other understandings coexisted, reflecting considerable pluralism. A wide range of challenges were associated with this concept, and further training was recommended by researchers.

Understanding and addressing barriers to communication in the context of neonatal neurologic injury: Exploring the ouR-HOPE approach.

Predicting neurologic outcomes for neonates with acute brain injury is essential for guiding the development of treatment goals and appropriate care plans in collaboration with parents and families. Prognostication helps parents imagine their child's possible future and helps them make ongoing treatment decisions in an informed way. However, great uncertainty surrounds neurologic prognostication for neonates, as well as biases and implicit attitudes that can impact clinicians' prognoses, all of which pose significant challenges to evidence-based prognostication in this context. In order to facilitate greater attention to these challenges and guide their navigation, this chapter explores the practice principles captured in the ouR-HOPE approach. This approach proposes the principles of Reflection, Humility, Open-mindedness, Partnership, and Engagement and related self-assessment questions to encourage clinicians to reflect on their practices and to engage with others in responding to challenges. We explore the meaning of each principle through five clinical cases involving neonatal neurologic injury, decision making, and parent-clinician communication. The ouR-HOPE approach should bring more cohesion to the sometimes disparate concerns reported in the literature and encourage clinicians and teams to consider its principles along with other guidelines and practices they find to be particularly helpful in guiding communication with parents and families.

Disclosure, consent, and the exercise of patient autonomy in surgical innovation: a systematic content analysis of the conceptual literature.

The classification of surgical innovation as clinical care, research, or as third distinct type of activity creates ambiguity which impacts standards for disclosure and informed consent. We conducted a systematic review of the conceptual literature to identify positions expressed about consent and disclosure, as well as major tension points associated with this issue. Literature overwhelmingly favors special consent and disclosure. Four major tension points were identified: the use of biasing/biased terminology to characterize innovation; patient vulnerability; the relationship between surgeon-innovator and patient; and practices and associated gaps related to consent and disclosure. Recommendations often focused on the informed consent process.